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Accelerate Diagnostics Announces FDA Clearance Of Its Accelerate Arc System, An Automated Platform Designed To Fight Against Sepsis And Antimicrobial Resistance

アクセレレートダイアグノスティクスは、アクセレレートアークシステムのFDA承認を発表しました。これは、敗血症および抗微生物薬のサポートに対抗するために設計された自動化プラットフォームです。

Benzinga ·  09/30 09:16

An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR)

Enables rapid, automated microbial identification on the Bruker MALDI Biotyper CA System directly from positive blood culture samples

TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ:AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform, for use with Bruker's MALDI Biotyper CA System (MBT-CA System) and MBT-CA Sepsityper software extension.

Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker's MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis.

The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with our future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs.

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